WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee - Sorbonne Université Access content directly
Journal Articles Journal of Rheumatology Year : 2022

WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee

Philip Conaghan
Robert Dworkin
  • Function : Author
Thomas Schnitzer
Francis Berenbaum
Andrew Bushmakin
  • Function : Author
Joseph Cappelleri
Lars Viktrup
Lucy Abraham

Abstract

Objective. To define meaningful within-patient change (MWPC) in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Methods. Data were analyzed separately from 3 phase III clinical trials (ClinicalTrials.gov: NCT02697773 , NCT02709486 , NCT02528188 ) of tanezumab, a novel treatment intended for the relief of signs and symptoms of moderate-to-severe osteoarthritis (OA), administered subcutaneously every 8 weeks. Patients with moderate-to-severe OA of the hip or knee completed the WOMAC and patient global assessment of OA (PGA-OA) at regular timepoints. A repeated measures longitudinal model with change in WOMAC Pain, Physical Function, or Stiffness domain score as the outcome and change in PGA-OA as the anchor was used to establish MWPC for WOMAC domains. Results. In the 3 studies, there were 688, 844, and 2948 subjects available for analyses, respectively. Analysis showed that a linear relationship between changes in WOMAC domains and changes in PGA-OA was supported and justified. Moreover, the relationships between these changes were very similar for 2 trials and close for the third. The estimated MWPC for the 3 WOMAC domains were from 0.84–1.16 (0–10 numerical rating scale) and from 12.50–16.23%, depending on study and domain, that corresponded to a 1-category change on PGA-OA. For a 2-category change those values were from 1.68–2.31 and from 25.01–32.46%, respectively. Conclusion. These results establish MWPCs for WOMAC domains, at the individual patient level, for patients with moderate-to-severe OA of the hip or knee. [ClinicalTrials.gov: NCT02697773 , NCT02709486 , and NCT02528188 ]

Dates and versions

hal-03995057 , version 1 (17-02-2023)

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Philip Conaghan, Robert Dworkin, Thomas Schnitzer, Francis Berenbaum, Andrew Bushmakin, et al.. WOMAC Meaningful Within-patient Change: Results From 3 Studies of Tanezumab in Patients With Moderate-to-severe Osteoarthritis of the Hip or Knee. Journal of Rheumatology, 2022, 49 (6), pp.615-621. ⟨10.3899/jrheum.210543⟩. ⟨hal-03995057⟩
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